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Antacid Recalls Grow
On December 11, 2019, RemedyRepack Inc. initiated a voluntary recall of 150-mg ranitidine tablets distributed in California and New York. The tablets were repackaged by RemedyRepack (original NDC 65162-0253-10, repackaged NDC 70518-1714-00) and were from lots J0376034-052319 (Exp. 5/20), J0406133-093019 (Exp. 10/20), J038005-082719 (Exp. 8/20), J0390280-072519 (Exp. 7/20), J0390277-072519 (Exp. 7/20), and J0349352-012519 (Exp. 1/20).
On December 20, 2019, Denton Pharma Inc. initiated a voluntary recall of ranitidine tablets that were repackaged by Northwind Pharmaceuticals and distributed throughout the United States. The recall includes the following products:
- 4-count bottles of 150-mg ranitidine tablets (NDC 70934-017-04) from lot N102851902 (Exp. 4/30/21);
- 20-count bottles of 150-mg ranitidine tablets (NDC 70934-017-20) from lot D102851801 (Exp. 4/21);
- 24-count bottles of 150-mg ranitidine tablets (NDC 70934-017-24) from lots N102851901 (Exp. 11/30/21), N102851903 (Exp. 12/31/21), and N102851906 (Exp. 3/31/22);
- 30-count bottles of 150-mg ranitidine tablets (NDC 70934-017-30) from lots N102851904 (Exp. 2/28/22) and N102851905 (Exp. 12/31/21);
- 90-count bottles of 150-mg ranitidine tablets (NDC 70934-017-90) from lots C102851901 (Exp. 11/30/21), C102851902 (Exp. 11/30/21), C102851903 (Exp. 11/30/21), C102851904 (Exp. 5/31/21), C102851905 (Exp. 2/28/22), C102851906 (Exp. 2/28/22), and C102851907 (Exp. 3/31/22);
- 15-count bottles of 300-mg ranitidine tablets (NDC 70934-287-15) from lots N106851901 (Exp. 11/30/21) and N106851902 (Exp. 10/31/21); and
- 90-count bottles of 300-mg ranitidine tablets (NDC 70934-287-90) from lots C106851901 (Exp. 11/30/21), C106851902 (Exp. 10/31/21), C106851903 (Exp. 2/28/22), C106851904 (Exp. 11/30/21), and C106851905 (Exp. 5/31/22).
On January 6, 2020, Pharma Pac initiated a voluntary recall of 150-mg ranitidine tablets distributed to physicians in California, Florida, North Carolina, and South Carolina. The tablets were packaged in counts of 7 (NDC 52959-0502-07), 14 (NDC 52959-0502-14), 20 (NDC 52959-0502-20), 30 (NDC 52959-0502-30), and 60 (52959-0502-60) and were from lots RAN63KG (Exp. 5/20), RAN64KG (Exp. 10/20), RAN65KG (Exp. 11/20), and RAN66KG (Exp. 5/21).
On January 7, 2020, Preferred Pharmaceuticals Inc. initiated a voluntary recall of all unexpired ranitidine tablets distributed in Alabama, Arizona, California, Florida, Georgia, Indiana, and South Carolina. The recall includes the following products:
- 30-count bottles of 150-mg ranitidine tablets (NDC 68788-7388-3);
- 60-count bottles of 150-mg ranitidine tablets (NDC 68788-7388-6);
- 90-count bottles of 150-mg ranitidine tablets (NDC 68788-7388-9);
- 100-count bottles of 150-mg ranitidine tablets (NDC 68788-7388-1);
- 14-count bottles of 300-mg ranitidine tablets (NDC 68788-6382-1);
- 30-count bottles of 300-mg ranitidine tablets (NDC: 68788-6382-3);
- 90-count bottles of 300-mg ranitidine tablets (NDC: 68788-6382-9); and
- 100-count bottles of 300-mg ranitidine tablets (NDC: 68788-6382-0).
The FDA designated the recalls Class II on January 20, 2020. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Prescription ranitidine is used in the treatment of ulcers, gastroesophageal reflux disease, and other conditions that cause excess stomach acid.
—Jolynn Tumolo